Sino-implant (II): Coalition welcomes eagerly-awaited WHO Prequalification

6th July 2017

On June 30, 2017, the World Health Organization (WHO) prequalified Sino-implant (II), a long-acting reversible contraceptive (LARC) implant marketed globally under the name of Levoplant. The Coalition celebrates this milestone as the culmination of more than a decade of committed collaboration between key Coalition partners and members: Shanghai Dahua Pharmaceutical Co., Ltd.; FHI 360; the Bill & Melinda Gates Foundation; the U.S. Agency for International Development (USAID); distributors including DKT, Marie Stopes International, and Pharm Access Africa Limited; as well as service delivery groups, national governments, and others. 

Sino-implant (II)/Levoplant has been prequalified for a 3-year duration of use with collection of safety and efficacy data ongoing during the fourth year.  It is a subdermal implant composed of two thin, flexible, silicone rods; each rod contains 75 mg of levonorgestrel, a synthetic progesterone. The implants are inserted under the skin of a woman's arm by a trained health care provider. 

This development contributes significantly to two key concepts underpinning the Coalition’s strategy -- Quality and Choice. Having a third quality-assured supplier will help sustain healthy markets for implants and help ensure ongoing affordability of commodities, guaranteeing there is sufficient supply, and providing countries and women with more choice. Like other contraceptive implants, Sino-implant (II)/Levoplant is one of the most effective family planning methods available. Each year, fewer than one pregnancy per 100 users is expected. Almost all women of childbearing age can use Sino-implant (II)/Levoplant: women of any age (with or without children), women in the immediate postpartum period, breastfeeding mothers, HIV-positive women, women who smoke and women who have had a miscarriage or an abortion. Sino-implant (II)/Levoplant is ideal for women with limited access to health services because it does not require regular resupply from a provider. 

Sino-implant (II)/Levoplant is manufactured in China by Shanghai Dahua Pharmaceutical Co. Ltd., which has been a member of the RHSC generic manufacturers’ group – the GEMS Caucus -- since its inception. Sino-implant (II)/Levoplant has been registered in more than 20 countries worldwide. FHI 360 provides technical assistance to facilitate the global introduction of Sino-implant (II)/Levoplant, including supporting the WHO prequalification application process, conducting independent quality testing, negotiating public-sector price-ceiling agreements, and working with distributors to secure national regulatory approvals. FHI 360 also leads clinical trials and collaborated on post-marketing surveillance studies in four countries with support from the Gates Foundation and USAID. Dahua and FHI 360 work in close coordination with a number of organizations, including government officials, distributors and service delivery groups, to facilitate introduction at the country level. More information is available here

Categories: Generic Manufacturers Caucus